Nivo/Ipi Combination Therapy in Symptomatic Brain Metastases

Brief description of study

The effect of nivolumab on symptomatic brain metastases is currently unknown. This phase 2
clinical trial will be the first to evaluate this intracranial effect in humans, with the aim
to give these patients the possibility to be treated with anti-PD-1. Besides the objective
response rate, long term benefits in this patient category will be evaluated by measuring
survival in terms of progression free survival and overall survival. Furthermore safety and
tolerability of administration of this drug in patients with symptomatic brain metastases
will be studied, as this is the first study for nivolumab in this specific patient category.

Detailed Study Description

This study is an open label, single arm, phase II clinical trial of prospectively collected
data evaluating efficacy and safety of nivolumab in metastatic melanoma patients with
symptomatic brain metastases. It will be conducted in several study centers in the
Netherlands.

Patients with radiologic evidence of brain metastases and who are eligible for treatment with
nivolumab will be screened for inclusion.

All patients in this trial will receive treatment with nivolumab for 24 months. Treatment
will be discontinued if confirmed disease progression has been demonstrated, if unacceptable
toxicity or intercurrent illness prevents further treatment, and when informed consent is
withdrawn. After discontinuation of treatment, follow-up will start. Duration of follow-up
depends on survival of patients, with a maximum of 24 months. Therefore the end of this study
is determined as 24 months after the last patient in this trial has started follow-up, has
died, withdraws consent or is lost to follow-up for a different reason.